ICH E6(R3)培训师高级研修班顺利落幕

2025-05-30 21:48:51

On May 20-21, the ICH E6(R3) Advanced Trainer Program, jointly organized by DIA China and the China Quality Assurance Forum (CQAF), was successfully held at the Hilton Shanghai Zhangjiang Science City. The event, packed with substantive content, received universal acclaim from regulatory authorities, clinical sites, and industry representatives.

5月20-21日，由DIA中国和CQAF（中国质量保证论坛）联合举办的ICH E6 (R3) 培训师高级研修项目在上海张江科学城希尔顿酒店圆满完成，干货满满，获得了来自药监、临床研究机构和工业界的一致好评。

ICH E6 (GCP) serves as the primary guiding principle and global standard for the design, conduct, evaluation, and oversight of clinical trials worldwide. R3 represents the first comprehensive revision of E6 (GCP) in two decades. Seizing this pivotal moment of transformation, Ms. Ping Zhang—Chair of the ICH E6(R3) EWG IFPMA topic lead, Chairperson of CQAF, and Head of Asia-Pacific R&D Quality Assurance at AstraZeneca—assembled an elite faculty from the ICH E6(R3) Global Expert Working Group, including: Gabriele Schwarz (EU Lead, GCP Strategy Expert at BfArM, Germany); Rebecca Stanbrook (EFPIA Lead, Head of Global Compliance & Regulatory Quality at Novartis); EWG Experts from CDE; Dr. Bo Fu (Annex 2 IFPMA Expert, Head of Statistics & Real-World Data Science at Astellas China), together with Ms. Hua Chen (Founder of CQAF, Senior GCP Consultant). These distinguished experts engaged in in-depth discussions with clinical trial professionals from China and the Asia-Pacific region (Japan, South Korea, and the Philippines).

ICH E6 (GCP) 是全球临床试验设计、实施、评价和监管的一级纲领性指导原则和国际通用标准。R3是20年来对 E6 (GCP) 的首次全面修订和变革。值此变革之际，ICH E6（R3）EWG IFPMA组长、中国质量保证论坛（CQAF）主席、阿斯利康亚太研发质量保证负责人张萍女士邀请ICH E6 (R3) 全球专家工作组成员，包括Gabriele SCHWARZ（欧盟组长、德国联邦药品和医疗器械研究所GCP战略专家）、Rebecca STANBROOK（EFPIA组长、诺华全球合规与监管质量负责人）、CDE的EWG专家和付博博士（Annex2 IFPMA专家、安斯泰来（中国）统计与真实世界数据科学负责人）以及CQAF创始人、资深GCP顾问陈华女士组成了豪华讲者阵容，与来自中国及亚太地区（日本、韩国和菲律宾）的临床试验专业人士进行了深度交流和探讨。

The program attracted nearly 100 senior practitioners, including representatives from regulatory agencies, clinical sites, and industry. Over two days of intensive training and exchange, participants deepened their understanding of GCP and expressed strong commitment to contributing to the implementation of E6(R3).

该项目吸引了近百位资深从业者参与。来自监管部门、临床研究机构以及工业界的代表。通过为期两天的系统培训与深入交流，与会者从不同视角深化了对GCP变革的理解，并对未来E6(R3)指南的落地实施贡献自己的力量更具信心。

The faculty emphasizedcore principles of E6(R3), including: "Fit for purpose", "Risk-proportionate" approaches and "Quality by Design", etc. They highlighted the importance of prospective planning, multidisciplinary collaboration, and risk proportionate execution of responsibilities under R3. For the evolving Annex 2, key takeaways included practical considerations for diverse design elements and data sources while adhering to the Annex 1 framework.

讲师团围绕 E6(R3) 中的“Fit for Purpose“, “Risk Proportionate”, “Quality by Design” 等核心理念，强调通过前瞻性规划和多学科协作设计临床试验，以风险相称的方式执行R3中各方职责的内容，以及应对各项要求的最佳实践。对于正在更改中的附录2，也讲述了要点，即在遵循附录1框架，强调多元化设计要素与数据源的实际应用考量。

Through interactive case studies, participants explored "how to implement" and "why these changes matter." Lively Q&A sessions bridged local operational challenges (e.g., acceptability of home nurses in pediatric trials in China, regional ethics review hurdles) with global best practices (risk-proportionate principles, essential record-keeping requirements). The dialogue underscored the need for mindset shifts—such as patient-centric flexibility and reducing unnecessary burdens—to harmonize R3 adoption across diverse regulatory landscapes.

现场所有与会者和讲师之间，围绕如何做，为何做，进行了实际案例的演练，在互动问答和感谢交流环节，弥合了本土操作挑战（如中国儿科试验中家庭护士的接受度、区域伦理审查障碍）与国际最佳实践（风险相称的原则、必备记录要求）之间的差异。对话深刻呼应了思维模式转变的需求（如患者为中心，提供灵活性，减少不必要的负担），以促进R3在不同监管环境中的协调应用。

The two-day training successfully connected global expertise (ICH EWG) with regional practices (Asia-Pacific), while amplifying China's unique perspectives in this transformative update. All attendees expressed enthusiasm for disseminating R3's new concepts and driving its implementation.

为期两天的培训成功搭建了全球专家智慧（ICH EWG）与亚太地区实践之间的桥梁，同时展现了中国在新变革中的独特见解和声音。所有与会者都表达了未来继续传播R3新理念并为推动落地做贡献的意愿。

Two senior ICH EWG experts remarked:"These two days of training allowed us to witness firsthand the professional excellence and passion of China's clinical trial community! Every second was worthwhile!" They noted that the rigorous attitude and innovative energy displayed not only injected new momentum into global standards implementation but also inspired every participant.

ICH EWG的两位资深专家也表示，“这两天的培训让我们深刻感受到中国临床试验工作者的专业实力与澎湃热情！Every second is worthwhile！”他们表示，大家展现出的严谨态度和创新活力，不仅为国际标准实践注入新动能，更让每一位参与者深受鼓舞。

The CQAF core team extends heartfelt gratitude to all speakers for their comprehensive insights and participants for their active engagement and vibrant discussions. Also appreciate IFPMA and NMPA for their guidance, DIA and CQAF staff for their seamless coordination. This program has not only equipped trainers to cascade R3 knowledge but also gathered critical feedback from regulators, research institutions, and industry—laying a solid foundation for R3's implementation and future training initiatives.

CQAF核心组成员在此衷心感谢所有演讲嘉宾的全面讲解，也感谢参会者在培训期间展现的热情及积极的互动分享。特别感谢IFPMA以及NMPA的指导，和DIA、CQAF工作人员和小伙伴们的大力支持和协作。本次培训不仅为培训师们提供了后续传播R3知识的能力，也听到了来自监管、临床研究机构和工业界的反馈和落地的见解，为接下来R3的落地实施以及后续的培训规划打下了坚实的基础。